The approval, granted under the EU Medical Device Regulation by DQS Medizinprodukte GmbH, marks the culmination of years of clinical trials and engineering development. Designed by a team of practicing neurointerventional physicians, the device is intended to handle aneurysm sizes ranging from 2 to 19 millimeters, offering a broader clinical range than many existing intrasaccular alternatives. The company leveraged data from its pivotal U.S. SEAL IT IDE trial to support the European application, positioning the system as a primary tool for complex neurovascular procedures.
Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics, described the certification as a pivotal moment for the firm’s international growth. With the European regulatory hurdle cleared, the company is now initiating a phased commercial rollout across selected markets. Beyond the European launch, Galaxy remains focused on domestic progress, with a Premarket Approval application currently under review by the U.S. Food and Drug Administration.
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